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PSURS: The Submission Process
Periodic Safety Update Reports (PSURs) are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product and are a legal requirement for certain medicinal products. Pharmaceutical companies are expected to write these reports and submit these to the regulatory authorities within a specific timeframe and at various intervals.
The legal requirements in the European Union for the submission of PSURs can be found in Regulation (EC) No 726/2004, Directive 2001/83/EC and in the Commission Implementing Regulation (EU) No 520/2012. The format is stipulated by the authorities and reports follow a specific structure.
The European Medicines Agency (EMA) publishes a list of EU reference dates which provides companies with the information they need to determine the frequency of their PSURs, the data lock points and the submission deadlines. The frequency of PSURs is determined using a risk-based approach and is therefore dependant on the inherent risk of the active substance(s). This EURD List is updated every 30 days and updates to these timelines should therefore be monitored by the company.
Marketing authorisation holders are responsible for submitting their own PSURs to the EMA according to the following timelines:
The EMA uses these reports to determine if there are new risks identified for a medicine or whether the balance of benefit vs risk has changed. The agency can then decide what actions is required in order to protect the public and inform healthcare providers and patients.
This obligation is waived for the following products:
It is therefore, extremely important for pharmacovigilance departments to understand the original route of application of a medicinal licence to enable them to determine what the company’s PSUR obligations are.
These reports must be submitted to authorities via the PSUR Repository (mandatory since 13th June 2016) as the submission of PSURs directly to national regulatory agencies (i.e. MHRA or HPRA) is no longer accepted and will result in non-compliance.
Currrently, the PSUR Repository will only accept PSUR reports in either eCTD or NeeS format and requires the submission to be accompanied by a .xml delivery file. In January 2018, eCTD submission became mandatory for centrally authorised, DCP and MRP licenced products. The goal of electronic submissions was to reduce the need for paper submission and the subsequent burden of archiving this data.
From 1st January 2019, the submission of PSURs will be accepted in eCTD format ONLY and will be extended to include national procedures as well. The submission of PSURs will therefore rely on obtaining the correct sequential numbers to facilitate PSUR submission and requires the full support of the Marketing Authorisation Holder in ensuring eCTD obligations are met and implemented in good time.
Having the correct software and validation tools to facilitate this is now essential.
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